Medical Monitor - Usona Institute

Usona Institute; Madison (WI); On-site; USD 100,000 - 150,000; Full time

Job summary

A leading clinical research organization is seeking a Medical Monitor to oversee safety and integrity in clinical trials. This role involves ensuring subject safety, providing medical oversight, and collaborating with cross-functional teams. Candidates should possess a medical degree and relevant experience in medical monitoring or pharmacovigilance, particularly in CNS or psychiatric development.

Qualifications

• 3–5 years of experience in medical monitoring or pharmacovigilance.
• Understanding of clinical trial conduct and safety regulations.
• Ability to interpret complex safety data.

Responsibilities

• Provide comprehensive daily medical oversight for clinical trials.
• Conduct safety signal detection activities.
• Monitor and assess protocol deviations.

Skills

Medical monitoring

Pharmacovigilance

Safety data interpretation

MedDRA coding

Clinical trial conduct

Education

Medical Degree (MD or DO)

Job description

Job Description

JOB OBJECTIVE: Reporting to the Chief Medical Officer or Senior Executive, the Medical Monitor is responsible for the ongoing medical oversight and safety monitoring of Usona-sponsored clinical trials. This role ensures subject safety, supports trial integrity, and provides real-time medical and scientific input during the execution of clinical trials. The Medical Monitor will serve as the primary medical liaison for internal stakeholders and CRO partners regarding trial-related medical issues. This position plays a pivotal role in providing medical oversight and ensuring data quality to support successful study execution.

CORE DUTIES:

1. Safety Oversight: Provide comprehensive daily medical oversight for clinical trials, including eligibility assessments, adverse event reviews, and safety data interpretation.
2. Conduct safety signal detection activities in collaboration with the pharmacovigilance team to monitor risks.
3. Coordinate with CRO medical monitors to align site-level decisions with study protocol.
4. Ensure accurate documentation of safety activities.

Clinical Trial Support:

1. Monitor and assess protocol deviations, providing medical input on eligibility and compliance.
2. Evaluate investigator-reported outcomes and participate in study continuation or discontinuation discussions.
3. Support internal quality reviews for medical decision consistency.

Data Review and Interpretation:

1. Collaborate with data management and statistical teams to review medical listings.
2. Review adverse event coding for accuracy.
3. Support interpretation of safety data and interim analyses.
4. Contribute to safety data reviews and summaries for leadership.

Regulatory and Compliance Support:

1. Conduct and document causality assessments for SAEs/SUSARs.
2. Partner with Regulatory Affairs and PV on safety reports.
3. Maintain understanding of regulatory reporting requirements.

Cross-Functional Collaboration:

1. Engage with various teams to facilitate study conduct.
2. Participate in safety review meetings and planning sessions.
3. Provide clinical insights on risk management and protocol amendments.

Additionally, the role involves demonstrating inclusion, practicing emotional and social intelligence, and complying with ethical and regulatory standards.

KEY QUALIFICATIONS:

• Medical Degree (MD or DO) with a background in psychiatry, neurology, or relevant specialty.
• 3–5 years of experience in medical monitoring or pharmacovigilance.
• Understanding of clinical trial conduct and safety regulations.
• Proficiency in MedDRA coding.
• Ability to interpret complex safety data and communicate clearly.

PREFERRED QUALIFICATIONS:

• Experience with Phase 2 or 3 trials, especially in CNS or psychiatric development.
• Knowledge of psychedelic research regulatory and operational aspects.
• Experience with SAE causality assessments.

PHYSICAL DEMANDS:

• Ability to remain stationary for extended periods.
• Minimal travel, with occasional meetings.

Usona is committed to diversity and equal opportunity employment, welcoming applicants from all backgrounds.